Lymphocyte Function Testing in Immuno-oncology

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard

About this trial

Several studies have shown that the presence and levels of IFN-γ may correlate with better responses to immunotherapy. Higher baseline levels of IFN-γ and an increase in its production during treatment have been associated with better clinical outcomes in patients receiving immunotherapy such as anti-PD-1/PD-L1 or anti-CTLA4.

To date, there is no simple, rapid, automated, and standardized test to assess T-cell functionality and quantify the level of immunosuppression in individual patients. To address this medical need, bioMérieux has developed the VIDAS® STIMM™ T RUO automated functional immune test, which can determine a patient's immune status by measuring IFN-γ production by T lymphocytes after stimulation by a mitogen in approximately four hours without human intervention. The aim of this study is to evaluate whether the amount of IFN-γ produced by T lymphocytes, as measured by an automated VIDAS® STIMM™ T functional immune test, correlates with disease progression in patients with advanced/metastatic solid tumors treated with standard immunotherapy.

Eligibility criteria

Qualifiers

Male or female aged 18 years or older with a confirmed diagnosis of solid tumors (any type of tumor) in advanced or metastatic stages

Cohort A: ICI without concomitant chemotherapy

Cohort B: ICI with concomitant chemotherapy

Patients who have understood, dated, and signed the consent form for this study before undergoing any protocol-specific procedures.

Disqualifiers

Patients to be treated with immunotherapy in combination with targeted therapy.

Patients treated with chemotherapy within the last 21 days prior to D1 of immunotherapy

Pregnant or breastfeeding patients.

Patients with other known cancers that are progressing or requiring the initiation of another treatment.

Trial design

Treatments tested in this trial

  • test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators